Back to resultsBridging the Gap by Transitional Care
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacist Counseling
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus Type 2 focused on measuring Adherence with discharge diabetes medications, Diabeted mellitus type 2 greater than one year, Patient with provider and prescriptions filled within CCHS
Eligibility Criteria
Inclusion Criteria:
- Males or females
- 18 to 85 years of age
- Historical diagnosis of type 2 diabetes mellitus greater than one year
- HbA1c concentration ≥ 8%
- Discharged from general medicine unit of John H. Stroger Jr, Hospital of Cook County
- Patient with provider and prescriptions filled within CCHS
Exclusion Criteria:
- Type 1 diabetes mellitus
- Pregnancy
- Major illness or debility, that prohibits the subject from participating in the study
- History of any hemoglobinopathy that may affect determination of HbA1c
- Non-English speaking patients
Sites / Locations
- John H. Stroger Jr. Hospital of Cook County
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Pharmacist Counseling
Standard therapy
Arm Description
Pharmacist Counseling includes but is not limited to: Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity
Standard therapy: Nurses distribute a education pamphlet on diabetes
Outcomes
Primary Outcome Measures
Adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management
The primary efficacy endpoint will be the difference in rate of adherence with medications Adherence will be assessed at 30, 60, 90, and 120 days following discharge An average of the total adherence rate 120 days following discharge will be calculated as the primary outcome measure
Secondary Outcome Measures
Change in A1c after 90 days
A1c measure as % and lipid panel 90 days following pharmacist counseling
To demonstrate an improvement in health literacy following pharmacist counseling on diabetes
To evaluate patient compliance with follow up appointments up to 90 days following pharmacist counseling
Change in BP after 90 days
BP in mm/Hg
Change in lipids after 90 days
Lipid measurements in mg/dL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01330121
Brief Title
Bridging the Gap by Transitional Care
Official Title
Pharmacist Discharge Counseling: Bridging the Gap by Transitional Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate patient adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management
Detailed Description
It is a prospective, randomized, controlled Study. Patients randomized in a 1:1 ratio to pharmacist counseling or standard of therapy prior to discharge.
Standard therapy: Nurses distribute a education pamphlet on diabetes.
Pharmacist Counseling includes but is not limited to:
Reviewing and explaining their medications (dosing, side effects, route)
Reviewing symptoms and complications of hyper and hypoglycemia
Defining glycemic & non-glycemic goal levels
Explaining the importance of compliance with medications & appointments
Educating on the basics of nutrition and physical activity
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Adherence with discharge diabetes medications, Diabeted mellitus type 2 greater than one year, Patient with provider and prescriptions filled within CCHS
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist Counseling
Arm Type
Active Comparator
Arm Description
Pharmacist Counseling includes but is not limited to:
Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity
Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
Standard therapy: Nurses distribute a education pamphlet on diabetes
Intervention Type
Other
Intervention Name(s)
Pharmacist Counseling
Intervention Description
Pharmacist Counseling includes but is not limited to:
Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity
Primary Outcome Measure Information:
Title
Adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management
Description
The primary efficacy endpoint will be the difference in rate of adherence with medications Adherence will be assessed at 30, 60, 90, and 120 days following discharge An average of the total adherence rate 120 days following discharge will be calculated as the primary outcome measure
Time Frame
up to 120 days
Secondary Outcome Measure Information:
Title
Change in A1c after 90 days
Description
A1c measure as % and lipid panel 90 days following pharmacist counseling
To demonstrate an improvement in health literacy following pharmacist counseling on diabetes
To evaluate patient compliance with follow up appointments up to 90 days following pharmacist counseling
Time Frame
up to 90 days
Title
Change in BP after 90 days
Description
BP in mm/Hg
Time Frame
up to 90 days
Title
Change in lipids after 90 days
Description
Lipid measurements in mg/dL
Time Frame
up to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females
18 to 85 years of age
Historical diagnosis of type 2 diabetes mellitus greater than one year
HbA1c concentration ≥ 8%
Discharged from general medicine unit of John H. Stroger Jr, Hospital of Cook County
Patient with provider and prescriptions filled within CCHS
Exclusion Criteria:
Type 1 diabetes mellitus
Pregnancy
Major illness or debility, that prohibits the subject from participating in the study
History of any hemoglobinopathy that may affect determination of HbA1c
Non-English speaking patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Fogelfeld, M.D.
Organizational Affiliation
John H. Stroger Hospital of Cook County, Division of Endocrinology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mansi Shah, PharmD
Organizational Affiliation
John H. Stroger Hospital of Cook County, Department of Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CaTanya Norwood, R.PH
Organizational Affiliation
John H. Stroger Hospital of Cook County, Department of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
John H. Stroger Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
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Bridging the Gap by Transitional Care
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